Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

GUDID 06977274260222

Changsha Honchon Technology Co., LTD

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• Primary Device ID: 06977274260222
• NIH Device Record Key: b99b1f63-8b8d-4507-b40e-e064787ca06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
• Version Model Number: UT-ML
• Company DUNS: 550050296
• Company Name: Changsha Honchon Technology Co., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977274260222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221051

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-31

On-Brand Devices [Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank]

• 06977274260222: UT-ML
• 06977274260215: UT-C
• 06977274260208: UT
• 06977274260192: 4D-Pro-ML
• 06977274260185: 4D-Plus-ML
• 06977274260178: 4D-ML
• 06977274260161: 3D-Pro-ML
• 06977274260154: 3D-Plus-ML
• 06977274260147: 3D-ML
• 06977274260130: SHT-ML
• 06977274260123: SHT-C
• 06977274260116: SHT
• 06977274260109: ST-ML
• 06977274260093: STP-C
• 06977274260086: ST-Plus
• 06977274260079: ST-C
• 06977274260062: ST
• 06977274260055: HTP-C
• 06977274260048: HT-Plus
• 06977274260031: HT-C
• 06977274260024: HT
• 06977274260017: HS